Label: EARCLEARRX- carbamide peroxide solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 12, 2021

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  • ACTIVE INGREDIENT

    Carbamide Peroxide USP 6.5%

  • USES

    For occasional use as an aid to soften, loosen, and remove excessive earwax.

  • WARNINGS

    Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. When using this product avoid contact with the eyes. Stop use and ask a doctor if you need to use for more than four days.

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222).

  • DIRECTIONS

    FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to four days if needed or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using an ear irrigation system.

  • INACTIVE INGREDIENTS

    Glycerin, Propylene Glycol, Sodium Bicarbonate, Lactic Acid, Purified Water

  • SPL UNCLASSIFIED SECTION

    Children under 12 years of age: consult a doctor before use.

  • Other information

    Do not store above 25°C (77°F).

  • Question or Comments

    (760) 362-8411

  • SPL UNCLASSIFIED SECTION

    Distributed by: Nuance Medical LLC

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

    EARCLEAR Rx™

    EAR WAX
    REMOVAL
    DROPS

    Active ingredients:
    Carbamide Peroxide USP 6.5%

    0.5 FL OZ (15 mL)
    NDC: 74318-102-05

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    EARCLEARRX 
    carbamide peroxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74318-102
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74318-102-0515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34401/01/2022
    Labeler - Nuance Medical, LLC (078797666)
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